PARADIGM Trial – Eligibility Criteria

Inclusion Criteria

Age ≥ 22

BMI ≤ 50 kg/m²

ASA score ≤ 3

Benign rectal or sigmoid lesion(s) (e.g., adenomas, neuroendocrine tumors, etc.)

Lesion size ≤ 7 cm and covering ≤ 75% of colorectal circumference

Eligible for standard endoscopic submucosal dissection

Exclusion Criteria

Anatomy unsuitable for endoluminal surgery

Active left-sided IBD

Active untreated infection

Vulnerable population

Severe illness limiting life expectancy

Pregnancy or breastfeeding

Enrollment in another clinical trial (within last 30 days)

EF ≤ 45, high cardiac or high pulmonary risk (unless cleared by cardiologist or pulmonologist, as applicable)

On blood thinners that cannot be safely weaned

Moderate to severe immunocompromised status

CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.

Final eligibility and consent will be determined by the Principal Investigator.